drugset / Trial / NCT07661641

A Study of [177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642 With [68Ga]Ga-A9-6217 or [177Lu]Lu-A9-0631 Imaging in GRPR+ Solid Tumors

NCT07661641 ↗

Phase 1 Recruiting 115 enrolled Alpha-9 Oncology USA Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 1-1b multicenter clinical study to evaluate the safety, efficacy, and dosimetry of \[177Lu\]Lu-A9-0631 and \[225Ac\]Ac-0642 in participants with Gastrin-Releasing Peptide Receptor (GRPR) expressing locally advanced, unresectable or metastatic solid tumors.

Timeline

Start
2026-07-01
Primary completion
2028-12
Completion
2029-12

Drugs

EvaluationDrugModalityDoseRoute
Subject [177Lu]Lu-A9-0631 Unknown — Intravenous
Subject [225Ac]Ac-A9-0642 Unknown — Intravenous